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Establishment method of release curve of rabeprazole sodium enteric-coated micro-pill capsule in acidic medium

A technology of rabeprazole sodium intestine and beprazole sodium intestine, which is applied in the direction of color/spectral property measurement, etc., can solve problems such as interference with measurement results, and achieve the effects of accurate establishment method, feasible operation and good reproducibility

Active Publication Date: 2015-11-04
广东彼迪药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the enteric-coated material of this product, hypromellose phthalate, also has strong absorption in the ultraviolet region. It dissolves at a pH above 5.5 and precipitates at a pH below 5.5. If UV-visible spectrophotometry is used, Enteric-coated excipients seriously interfere with the test results

Method used

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  • Establishment method of release curve of rabeprazole sodium enteric-coated micro-pill capsule in acidic medium
  • Establishment method of release curve of rabeprazole sodium enteric-coated micro-pill capsule in acidic medium
  • Establishment method of release curve of rabeprazole sodium enteric-coated micro-pill capsule in acidic medium

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Experimental program
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Effect test

Embodiment 1

[0041] Accurately weigh 10 mg of rabeprazole sodium reference substance, add 0.1 mol / L hydrochloric acid solution to dissolve and dilute to make a solution containing 1 μg per 1 ml, put it in a water bath at 37.0 °C ± 0.5 °C, at 0, 30, 60, 90 1. At 120 minutes, take an appropriate amount of solution, cool to room temperature, and scan at a wavelength of 200-400 nm at different times according to UV-Vis spectrophotometry. The stability spectrogram of reference substance solution under 0.1mol / L hydrochloric acid solution sees figure 1 . The UV spectrum of each solution has a stable absorbance at 298nm.

Embodiment 2

[0043] Accurately weigh 10 mg of rabeprazole sodium reference substance, add pH 6.0 phosphate buffer to dissolve and dilute to a solution containing 10 μg per 1 ml, put it in a water bath at 37.0°C±0.5°C, and set the temperature at 0, 30, 60, and 90°C respectively. 120 minutes, take an appropriate amount of solution, cool to room temperature, accurately measure 9ml and add 1ml 1mol / L hydrochloric acid solution, and scan at a wavelength of 200-400nm at different times according to ultraviolet-visible spectrophotometry. The stability spectrogram of the reference substance solution under the pH6.0 phosphate buffer solution is shown in figure 2 . figure 2 The first and second spectral lines at 298nm from top to bottom are the spectral lines of 0h and 1h at room temperature placed in a water bath at 37.0°C for 30 minutes, and the UV spectra of each solution are stable at 298nm except for 30 minutes at 37.0°C in a water bath of absorbance. Therefore, it is necessary to place the e...

Embodiment 3

[0045] Accurately weigh 10mg of rabeprazole sodium reference substance, add pH6.8 phosphate buffer to dissolve and dilute to a solution containing 10μg per 1ml, put it in a water bath at 37.0°C ± 0.5°C, and set at 0, 30, 60, 90 120 minutes, take an appropriate amount of solution, cool to room temperature, accurately measure 9ml and add 1.2ml 1mol / L hydrochloric acid solution, and scan at a wavelength of 200-400nm at different times according to ultraviolet-visible spectrophotometry. The stability spectrogram of the reference substance solution under the pH6.8 phosphate buffer solution is shown in image 3 . The UV spectrum of each solution has a stable absorbance at 298nm.

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Abstract

The invention discloses an establishment method of a release curve of a rabeprazole sodium enteric-coated micro-pill capsule in an acidic medium. The method comprises the steps: taking the rabeprazole sodium enteric-coated micro-pill capsule, adopting an oar-method device, taking the acidic medium as a release medium, respectively taking solutions at different rotation speeds and time points, filtering, measuring to take the dissolution filtrate, carrying out appropriate treatment, and then taking the treated filtrate as a test sample solution; additionally taking a rabeprazole sodium reference substance, adding the acidic medium, carrying out appropriate treatment, and thus obtaining a reference substance solution; and measuring the absorbance by using an ultraviolet-visible spectrophotometry, calculating the release degree and drawing the release curve. The method overcomes the defects that rabeprazole sodium is easy to degrade in the acidic medium and is difficult to effectively detect by high performance liquid chromatography, and enteric-coated accessories seriously interfere determination results in ultraviolet-visible spectrophotometry, innovatively adopts simple acid addition precipitation centrifugation to remove accessory interference, detects degradation products of rabeprazole sodium, indirectly detects the rabeprazole sodium release degree, and has the advantages of being simple, quick and accurate.

Description

technical field [0001] The invention belongs to the field of analysis and detection of pharmaceutical preparations, and more specifically, the invention relates to a method for establishing a release curve of rabeprazole sodium enteric-coated pellets and capsules in an acidic medium. Background technique [0002] Rabeprazole sodium has a large dissociation constant and is a partially reversible H+ / K+-ATPase inhibitor with less side effects and more binding targets. It acts faster and has higher antacid intensity than other drugs Strong advantages, mainly used for gastric ulcer, duodenal ulcer, reflux esophagitis, Zollinger-Ellison syndrome (gastrinoma). [0003] It has been reported in the literature that the release of rabeprazole sodium enteric-coated preparations in pH6.8 phosphate buffer can be detected by measuring the absorbance at 282nm by UV-visible spectrophotometry; but this method is based on the interference of preparation excipients. carried out while ignoring....

Claims

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Application Information

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IPC IPC(8): G01N21/33
Inventor 谭银合钟露露蒋林波赵明馨杨新明
Owner 广东彼迪药业有限公司
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